MSAT Senior Technology SME
GSK
June 29, 2026
Remote friendly (Marietta, PA)
United States
Operations
Position Summary
You will be an experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States, supporting commercial Drug Substance and Drug Product Vaccine manufacture with technical lifecycle ownership in areas such as mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling and AVI. Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers from donor sites for new and established products.
Responsibilities
- Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness initiatives, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/development knowledge into robust, scalable manufacturing processes.
- Design and run experiments for process characterization, optimization, and validation.
- Support inspection readiness and audit activities.
- Define and deploy process control strategies, performance standards, and lifecycle monitoring.
- Provide technical input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams and MSAT peers.
- Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.
Basic Qualifications (Required)
- Bachelor’s degree in a relevant scientific/engineering discipline.
- 5+ years’ experience in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on experience with technology transfers, scale-up, process validation, and lifecycle management in a regulated environment.
- Practical knowledge of mixing/homogeneity, chromatography, filtration, ultrafiltration/diafiltration, and aseptic processing.
- Experience leading technical investigations, root cause analysis, and CAPA development.
- Experience using data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s or PhD.
- Experience with sterile manufacturing/aseptic processing.
- Background in extractables/leachables, material qualification, or supplier component assessments.
- Knowledge of regulatory expectations for process validation/continued process verification.
- Experience leading cross-functional projects and mentoring; Lean/Six Sigma or similar training.
Work arrangement
Hybrid; on-site regularly to support manufacturing/operational readiness and technical transfer work.
Application Instructions
Submit your resume and a brief note describing a recent technical transfer, validation, or investigation you led or supported.
You will be an experienced Manufacturing Science & Technology (MSAT) Senior Technology Subject Matter Expert (SME) in the United States, supporting commercial Drug Substance and Drug Product Vaccine manufacture with technical lifecycle ownership in areas such as mixing/homogeneity, ultrafiltration/diafiltration, chromatography, formulation, aseptic filling and AVI. Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness, and technology transfers from donor sites for new and established products.
Responsibilities
- Lead technical strategy, troubleshooting, manufacturing scale-up, process robustness initiatives, technology transfers, lifecycle changes, and technical reviews.
- Provide SME leadership for investigations, root cause analysis, CAPA, and regulatory responses.
- Translate lab/development knowledge into robust, scalable manufacturing processes.
- Design and run experiments for process characterization, optimization, and validation.
- Support inspection readiness and audit activities.
- Define and deploy process control strategies, performance standards, and lifecycle monitoring.
- Provide technical input to change controls, risk assessments, and corrective actions.
- Train, coach, and mentor cross-functional teams and MSAT peers.
- Drive continuous improvement by identifying technical improvements, leading implementation, and tracking outcomes.
Basic Qualifications (Required)
- Bachelor’s degree in a relevant scientific/engineering discipline.
- 5+ years’ experience in pharmaceutical vaccines/biologics manufacturing technical operations.
- Hands-on experience with technology transfers, scale-up, process validation, and lifecycle management in a regulated environment.
- Practical knowledge of mixing/homogeneity, chromatography, filtration, ultrafiltration/diafiltration, and aseptic processing.
- Experience leading technical investigations, root cause analysis, and CAPA development.
- Experience using data analysis and advanced statistical methods for process understanding.
- Knowledge of GMP and regulatory expectations.
Preferred Qualifications
- Master’s or PhD.
- Experience with sterile manufacturing/aseptic processing.
- Background in extractables/leachables, material qualification, or supplier component assessments.
- Knowledge of regulatory expectations for process validation/continued process verification.
- Experience leading cross-functional projects and mentoring; Lean/Six Sigma or similar training.
Work arrangement
Hybrid; on-site regularly to support manufacturing/operational readiness and technical transfer work.
Application Instructions
Submit your resume and a brief note describing a recent technical transfer, validation, or investigation you led or supported.